Fetzima
- Product NDC
- 0456-2200
- 11-digit product format
- 004562200
- Labeler code
- 0456
- Product ID
- 0456-2200_b4f9c587-d1eb-462b-bad2-ed0ce6d76c57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVOMILNACIPRAN HYDROCHLORIDE
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Allergan, Inc.
- Application
- NDA204168
- Marketing category
- NDA
- Marketing start
- 2023-03-24
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204168-001 | FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 |
| N204168-002 | FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 |
| N204168-003 | FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 |
| N204168-004 | FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2013-07-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N204168-001 | AB |
| N204168-002 | AB |
| N204168-003 | AB |
| N204168-004 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204168-001 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | |
| N204168-001 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | |
| N204168-001 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | |
| N204168-002 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | |
| N204168-002 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | |
| N204168-002 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | |
| N204168-003 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | |
| N204168-003 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | |
| N204168-003 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | |
| N204168-004 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | |
| N204168-004 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | |
| N204168-004 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N204168-001 | M-304 | 2026-03-24 |
| N204168-002 | M-304 | 2026-03-24 |
| N204168-003 | M-304 | 2026-03-24 |
| N204168-004 | M-304 | 2026-03-24 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N204168-001 | FETZIMA | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204168-002 | FETZIMA | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204168-003 | FETZIMA | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204168-004 | FETZIMA | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2013-07-25 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-001 | FETZIMA | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-002 | FETZIMA | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-003 | FETZIMA | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-004 | FETZIMA | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2013-07-25 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-001 | FETZIMA | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-002 | FETZIMA | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-003 | FETZIMA | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-004 | FETZIMA | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2013-07-25 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-001 | FETZIMA | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-002 | FETZIMA | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-003 | FETZIMA | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2013-07-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-004 | FETZIMA | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2013-07-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N204168-001 | FETZIMA | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204168-002 | FETZIMA | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204168-003 | FETZIMA | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204168-004 | FETZIMA | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2013-07-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204168-001 | FETZIMA | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204168-002 | FETZIMA | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204168-003 | FETZIMA | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204168-004 | FETZIMA | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2013-07-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204168-001 | FETZIMA | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204168-002 | FETZIMA | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204168-003 | FETZIMA | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204168-004 | FETZIMA | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2013-07-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204168-001 | FETZIMA | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204168-002 | FETZIMA | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204168-003 | FETZIMA | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204168-004 | FETZIMA | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2013-07-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204168-001 | FETZIMA | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204168-002 | FETZIMA | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204168-003 | FETZIMA | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204168-004 | FETZIMA | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2013-07-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204168-001 | FETZIMA | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204168-002 | FETZIMA | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204168-003 | FETZIMA | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2013-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204168-004 | FETZIMA | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2013-07-25 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N204168-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204168-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204168-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204168-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-004 | AB | 1 | 31067a03dcf5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N204168-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N204168-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N204168-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N204168-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N204168-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N204168-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N204168-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N204168-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N204168-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N204168-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N204168-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N204168-004 | AB | 1 | 8869cabd3fbd… |
| 2023-01-26 05:58 UTC | 2023-01 | N204168-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N204168-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N204168-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N204168-004 | AB | 1 | 3bdfa0b2c4d7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204168-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204168-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204168-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204168-004 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N204168-001 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204168-001 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204168-001 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204168-002 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204168-002 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204168-002 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204168-003 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204168-003 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204168-003 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204168-004 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204168-004 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204168-004 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-001 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-001 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-001 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-002 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-002 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-002 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-003 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-003 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-003 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-004 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-004 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204168-004 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-001 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-001 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-001 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-002 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-002 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-002 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-003 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-003 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-003 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-004 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-004 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-004 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-001 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-001 | 8481598 | 2031-03-02 | U-839 | 2013-08-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-001 | 8865937 | 2032-05-23 | Drug substance, Drug product | 2014-11-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-002 | RE43879 | 2026-01-11 | U-839 | 2013-08-15 | 31067a03dcf5… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N204168-001 | M-304 | 2026-03-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204168-002 | M-304 | 2026-03-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204168-003 | M-304 | 2026-03-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204168-004 | M-304 | 2026-03-24 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-001 | M-304 | 2026-03-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-002 | M-304 | 2026-03-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-003 | M-304 | 2026-03-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204168-004 | M-304 | 2026-03-24 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-001 | M-304 | 2026-03-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-002 | M-304 | 2026-03-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-003 | M-304 | 2026-03-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204168-004 | M-304 | 2026-03-24 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-001 | M-304 | 2026-03-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-002 | M-304 | 2026-03-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-003 | M-304 | 2026-03-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204168-004 | M-304 | 2026-03-24 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N204168-001 | M-304 | 2026-03-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204168-002 | M-304 | 2026-03-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204168-003 | M-304 | 2026-03-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204168-004 | M-304 | 2026-03-24 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204168-001 | M-304 | 2026-03-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204168-002 | M-304 | 2026-03-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204168-003 | M-304 | 2026-03-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204168-004 | M-304 | 2026-03-24 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204168-001 | M-304 | 2026-03-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204168-002 | M-304 | 2026-03-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204168-003 | M-304 | 2026-03-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204168-004 | M-304 | 2026-03-24 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204168-001 | M-304 | 2026-03-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204168-002 | M-304 | 2026-03-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204168-003 | M-304 | 2026-03-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204168-004 | M-304 | 2026-03-24 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204168-001 | M-304 | 2026-03-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204168-002 | M-304 | 2026-03-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204168-003 | M-304 | 2026-03-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204168-004 | M-304 | 2026-03-24 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204168-001 | M-304 | 2026-03-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204168-002 | M-304 | 2026-03-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204168-003 | M-304 | 2026-03-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204168-004 | M-304 | 2026-03-24 | 5bbf6a4d5a75… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fetzima
- Listing expiration
- 2027-12-31
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 371U2ZK31U | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1433217 | Internal RxNorm lookup |
| 1433223 | Internal RxNorm lookup |
| 1433227 | Internal RxNorm lookup |
| 1433229 | Internal RxNorm lookup |
| 1433233 | Internal RxNorm lookup |
| 1433235 | Internal RxNorm lookup |
| 1433239 | Internal RxNorm lookup |
| 1433241 | Internal RxNorm lookup |
| 1433249 | Internal RxNorm lookup |
| 1433250 | Internal RxNorm lookup |
| 2636817 | Internal RxNorm lookup |
| 2636818 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f371258d-91b3-4b6a-ac99-434a1964c3af | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7efbf4fa-913e-470a-89c4-2a84490ad12a | Product name | 4 | 20240320 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0456-2200-07 | Fetzima | 1 in 1 CARTON | KIT | 1 | 33 | |
| 0456-2200-65 | Fetzima | 1 in 1 BLISTER PACK | KIT | 1 | 33 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0456-2200 | FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [ALLERGAN, INC.] | 31 | Current NDC, 2 package rows | 20240502_f371258d-91b3-4b6a-ac99-434a1964c3af.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fetzima | LEVOMILNACIPRAN HYDROCHLORIDE | Allergan, Inc. | f371258d-91b3-4b6a-ac99-434a1964c3af | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 204168 NDA204168 0456-2200 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1433250 | {2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule [Fetzima]) / 26 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule [Fetzima]) } Pack [Fetzima Pack] | BPCK | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 2636818 | {2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule [Fetzima]) / 5 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule [Fetzima]) } Pack [Fetzima Titration Sample Pack] | BPCK | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433249 | {2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule) / 26 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule) } Pack | GPCK | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 2636817 | {2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule) / 5 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule) } Pack | GPCK | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433223 | Fetzima 120 MG 24HR Extended Release Oral Capsule | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433229 | Fetzima 20 MG 24HR Extended Release Oral Capsule | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433235 | Fetzima 40 MG 24HR Extended Release Oral Capsule | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433241 | Fetzima 80 MG 24HR Extended Release Oral Capsule | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433250 | Fetzima Titration Pack, 20 MG (2), 40 MG (26) | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 2636818 | Fetzima Titration Sample Pack, 20 MG (2), 40 MG (5) | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433217 | levomilnacipran 120 MG 24HR Extended Release Oral Capsule | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433227 | levomilnacipran 20 MG 24HR Extended Release Oral Capsule | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433249 | levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (26) Pack | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 2636817 | levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (5) Pack | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433233 | levomilnacipran 40 MG 24HR Extended Release Oral Capsule | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433239 | levomilnacipran 80 MG 24HR Extended Release Oral Capsule | PSN | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433223 | 24 HR levomilnacipran 120 MG Extended Release Oral Capsule [Fetzima] | SBD | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433229 | 24 HR levomilnacipran 20 MG Extended Release Oral Capsule [Fetzima] | SBD | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433235 | 24 HR levomilnacipran 40 MG Extended Release Oral Capsule [Fetzima] | SBD | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433241 | 24 HR levomilnacipran 80 MG Extended Release Oral Capsule [Fetzima] | SBD | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433217 | 24 HR levomilnacipran 120 MG Extended Release Oral Capsule | SCD | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433227 | 24 HR levomilnacipran 20 MG Extended Release Oral Capsule | SCD | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433233 | 24 HR levomilnacipran 40 MG Extended Release Oral Capsule | SCD | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433239 | 24 HR levomilnacipran 80 MG Extended Release Oral Capsule | SCD | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433223 | 24 HR Fetzima 120 MG Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433229 | 24 HR Fetzima 20 MG Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433235 | 24 HR Fetzima 40 MG Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433241 | 24 HR Fetzima 80 MG Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433223 | Fetzima (levomilnacipran 120 MG (as levomilnacipran hydrochloride 137.8 MG)) 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433229 | Fetzima (levomilnacipran 20 MG (as levomilnacipran hydrochloride 23 MG)) 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433235 | Fetzima (levomilnacipran 40 MG (as levomilnacipran hydrochloride 45.9 MG)) 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433241 | Fetzima (levomilnacipran 80 MG (as levomilnacipran hydrochloride 91.8 MG)) 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433223 | Fetzima 120 MG 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433229 | Fetzima 20 MG 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433235 | Fetzima 40 MG 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433241 | Fetzima 80 MG 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433250 | Fetzima Titration Pack | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 2636818 | Fetzima Titration Sample Pack | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433217 | levomilnacipran 120 MG (as levomilnacipran hydrochloride 137.8 MG) 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433227 | levomilnacipran 20 MG (as levomilnacipran hydrochloride 23 MG) 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433249 | levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (26) Pack (Capsule) | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 2636817 | levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (5) Pack | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433233 | levomilnacipran 40 MG (as levomilnacipran hydrochloride 45.9 MG) 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433233 | levomilnacipran 40 MG 24HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433239 | levomilnacipran 80 MG (as levomilnacipran hydrochloride 91.8 MG) 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
| 1433239 | levomilnacipran 80 MG 24 HR Extended Release Oral Capsule | SY | f371258d-91b3-4b6a-ac99-434a1964c3af | 33 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0456-2200-07 | 00456220007 | 1 BLISTER PACK in 1 CARTON (0456-2200-07) / 1 KIT in 1 BLISTER PACK (0456-2200-65) * 2 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2220-00) * 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2240-00) | 1 blister pack | 2023-03-24 | Yes | No | Current |
| 0456-2200-65 | 00456220065 | 1 in 1 BLISTER PACK | Historical |